Ver­sant care­ful­ly sets the stage for a $68M de­but of a biotech play­er fo­cused on syn­thet­ic lethal­i­ty

Over the past 18 months, the grow­ing team at Re­pare Ther­a­peu­tics has been qui­et­ly set­ting up shop in Ver­sant Ven­tures’ dis­cov­ery ops and fo­cus­ing on syn­thet­ic lethal­i­ty — the ther­a­peu­tic in­ter­play be­tween ge­net­ic mu­ta­tions and can­cer. Us­ing CRISPR gene edit­ing tech as an in­ter­ro­ga­tion tool, they’ve been play­ing with well known tar­gets like p53 and BR­CA1 to find out how they con­spire with oth­er mu­ta­tions in the de­struc­tion of a ma­lig­nan­cy, fol­low­ing the trail of le­sions in the pur­suit of new ther­a­pies that can work in the same fun­da­men­tal way those PARP in­hibitors you’ve been hear­ing so much about can fight can­cer.

The goal was to mas­ter syn­thet­ic lethal­i­ty and iden­ti­fy the first cou­ple of tar­gets to go af­ter in the clin­ic. They lined up their team, now at 20, li­censed in dis­cov­ery work from NYU on a poly­merase im­pli­cat­ed in nu­mer­ous can­cers, and to­day will come out of stealth mode with a $68 mil­lion round and at least a four-year run­way with plans to start tack­ling clin­i­cal work in late 2019.

Their first pro­gram in­volves DNA-di­rect­ed DNA poly­merase theta — PolQ — in­clud­ed in a path­way that re­pairs dou­ble-strand breaks in can­cer cells. And while they have a ways to go be­fore they be­gin hu­man stud­ies, the in­vestors are send­ing a mes­sage that the amount of cash they’re bet­ting on Re­pare in­di­cates a high lev­el of con­fi­dence for their longterm suc­cess.

Jer­el Davis

“In terms of the in­cu­ba­tion pe­ri­od,” says Jer­el Davis, man­ag­ing di­rec­tor at Ver­sant, “this com­pa­ny is de­cep­tive­ly ma­ture.”

“The time we’ve been able to spend in stealth al­lowed us to build the com­pa­ny out of the spot­light,” says CEO Lloyd Se­gal. In Mon­tre­al they have de­vel­oped their med­i­c­i­nal chem­istry team un­der Cameron Black, the for­mer head of chem­istry at Mer­ck Frosst who joined a lit­tle more than a year ago. And when Ver­tex re­cent­ly shut down in Mon­tre­al, they swooped in, grab­bing an ex­pe­ri­enced team with a long track record of work­ing to­geth­er.

Lloyd Se­gal

With­in hours of the shut­down, they had 13 new re­cruits out of 14 of­fers.

R&D head Michael Zin­da, who led As­traZeneca On­col­o­gy iMed Bio­science group in Boston, is head­ing up the oth­er group in Cam­bridge, MA.

Ver­sant has gath­ered an im­pres­sive group of mar­quee in­vestors to back their up­start. MPM Cap­i­tal came in along­side as the lead in­vestor on the Se­ries A, with Cel­gene’s Swiss of­fice tak­ing part along with FTQ and BDC Ven­tures.

“We could have tak­en more mon­ey,” Se­gal tells me. “We had more than that on the ta­ble. But we be­lieved that was the kind of mon­ey that we hope will take two com­pounds in­to the clin­ic in late ’19 or ear­ly 2020.”

Ver­sant had a front row seat on some of the ear­ly work on syn­thet­ic lethal­i­ty at Clo­vis while it was work­ing on PARP, says Davis. “This is a field we know and our con­vic­tion is that PARP is the tip off the ice­berg.”

Re­pare has the plat­form that they plan to use to map out some of the rest of the un­ex­plored ter­ri­to­ry.

Even with­out R&D part­ners Se­gal feels that he has enough cash to make their way through at least the first 4 years. Add in the prospect of some ma­jor league play­ers com­ing in to part­ner on key prospects, and that run­way will stretch fur­ther. If it all plays out ac­cord­ing to plan, Se­gal adds, this will be their last ven­ture raise.

It’s an am­bi­tious plan, with some stel­lar sci­en­tif­ic ad­vis­ers ready to leaned guid­ance. The full sci­en­tif­ic ad­vi­so­ry board in­cludes:

– Samuel Apari­cio, pro­fes­sor in the de­part­ment of pathol­o­gy and lab­o­ra­to­ry med­i­cine at the Uni­ver­si­ty of British Co­lum­bia.

– Jim Carmichael, head of the pro­tein home­osta­sis the­mat­ic cen­ter of ex­cel­lence at Cel­gene. He pre­vi­ous­ly was UK re­gion­al di­rec­tor of med­ical sci­ence at As­traZeneca fol­low­ing its ac­qui­si­tion of Ku­DOS, where he was CMO and re­spon­si­ble for clin­i­cal de­vel­op­ment of ola­parib.

– Ron­ny Drap­kin, di­rec­tor of the Penn Ovar­i­an Can­cer Re­search Cen­ter and di­rec­tor of gy­ne­co­log­ic can­cer re­search at the Uni­ver­si­ty of Penn­syl­va­nia.

– Lau­rie Glim­ch­er, pres­i­dent and CEO of the Dana-Far­ber Can­cer In­sti­tute.

– Mark Pe­gram, di­rec­tor of the breast can­cer on­col­o­gy pro­gram at Stan­ford Women’s Can­cer Cen­ter and co-di­rec­tor of Stan­ford’s mol­e­c­u­lar ther­a­peu­tics pro­gram.

– Richard Wood, pro­fes­sor of mol­e­c­u­lar bi­ol­o­gy at the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter.

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

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Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: Bris­tol My­ers sus­pends clin­i­cal tri­als, grounds field team; Vir ush­ers an­ti­body can­di­dates to hu­man test­ing

The global nature of the Covid-19 pandemic is manifesting more profoundly every day. With Spain’s death toll now surpassing China’s and India on full lockdown, the number of confirmed cases around the world has exceeded 436,000 while recoveries edged close to 112,000.

While the outbreak derails R&D at another pharma giant, several drugmakers have some encouraging updates on both experimental and repurposed molecules. Philanthropic campaigns in anticipation of the economic fallout continue. An Australian biotech is taking extreme measures to hunker down. There’s also an alternative epidemiology model emerging out of the UK, stirring up more discussion regarding the true extent of the infections in the country.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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